Using probiotics to help patients after diverticulitis

Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.

This study is testing if a probiotic can help people who have had diverticulitis feel better and improve their gut health over three to six months.

Quick facts

• Study type: Observational
• Enrollment: 145 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Roma La Sapienza (other)
• Locations: 12 sites (Catanzaro, Calabria and 11 other locations)
• Trial ID: NCT06040515 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the efficacy and safety of the probiotic Escherichia coli Nissle 1917 in patients who have experienced acute colonic diverticulitis. It aims to determine if the probiotic can significantly reduce symptoms and assess changes in microbiota over time. The study will compare microbiota differences between symptomatic and asymptomatic patients and explore correlations between microbiota changes and symptom relief during follow-up. Participants will be monitored for three to six months after treatment with the probiotic.

Who should consider this trial

Good fit: Ideal candidates include symptomatic patients three months post-uncomplicated diverticulitis or six months post-complicated diverticulitis, as well as asymptomatic patients after similar episodes.

Not a fit: Patients currently experiencing acute diverticulitis or those with chronic inflammatory bowel diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for managing symptoms in patients recovering from diverticulitis.

How similar studies have performed: While the use of probiotics in gastrointestinal conditions is well-studied, this specific application in diverticulitis is less common and may provide novel insights.

Eligibility criteria

Inclusion Criteria:

* Symptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
* Symptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to .surgical colonic resection without stoma;
* Patients with diverticulosis;
* Asymptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
* Asymptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to surgical colonic resection without stoma.

Exclusion Criteria:

* Ongoing acute diverticulitis at radiologic assessment
* Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine within four weeks before enrolment;
* Lactulose-lactitol use within four weeks before enrolment;
* Presence of chronic inflammatory bowel diseases;
* Presence of Segmental Colitis Associated with Diverticulitis (SCAD);
* Presence of ischemic colitis;
* Severe chronic liver (Child-Pugh C) and/or pancreatic and/or renal diseases;
* Patients with severe renal failure;
* Presence of suspected/actual pregnancy;
* Presence of recent/ongoing neoplasia, under oncological treatment within 6 months before enrolment;
* Presence of COVID-19 infection;
* Patients unable to give informed consent.

Where this trial is running

Catanzaro, Calabria and 11 other locations

• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio — Catanzaro, Calabria, Italy (RECRUITING)
• UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti" — Latina, Lazio, Italy (RECRUITING)
• UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini" — Roma, Lazio, Italy (RECRUITING)
• UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I" — Roma, Lazio, Italy (RECRUITING)
• UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re" — Roma, Lazio, Italy (RECRUITING)
• UOC Chirurgia Generale, Ospedale "P. Colombo" — Velletri, Lazio, Italy (RECRUITING)
• UOC di Gastroenterologia, Ospedale "Belcolle", — Viterbo, Lazio, Italy (RECRUITING)
• • UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele" — Milan, Lombardia, Italy (RECRUITING)
• UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova — Padova, Lombardia, Italy (RECRUITING)
• UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto" — Piacenza, Lombardia, Italy (RECRUITING)
• UOC di Gastroenterologia, Ospedale "S. Salvatore", — Pesaro, Marche, Italy (RECRUITING)
• Gastroenterology Service , ASL BAT, — Andria, Italy (RECRUITING)

Study contacts

• Principal investigator: Walter Elisei, MD — • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
• Study coordinator: Antonio Tursi, MD, PhD

Conditions: Diverticulitis, Colonic, Therapy